Linear rotation stabilizer for a telescoping syringe stopper driverdriving assembly

ABSTRACT

A cartridge interface assembly drives a stopper in a drug reservoir or a drug delivery device. An anti-rotational guide optionally moves along an axis of a cavity of the reservoir. The anti-rotational guide is optionally slidably anti-rotationally coupled to a housing of the drug delivery device. A telescoping plunger driver may include a proximal shaft and distal shaft that telescope by relative rotation. The distal shaft is optionally slidably anti-rotationally coupled to the anti-rotational guide. The shafts are optionally oriented along said axis. In some embodiments, rotating the proximal shaft with respect to the anti-rotational guide moves the guide along said axis with respect to the housing and moves the distal shaft along the axis with respect to the anti-rotational guide.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of similarly titled U.S.application Ser. No. 14/725,009, filed on May 29, 2015, the entirecontents of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to a stopperdriver for a drug delivery device and, more particularly, but notexclusively, to a telescoping stopper driver of a drug cartridge.

U.S. Pat. No. 6,800,071 discloses, “an improved pump, reservoir andreservoir piston for,” “controlled delivery of fluids. A motor isoperably coupled to a drive member, such as a drive screw, which isadapted to advance a plunger slide in response to operation of themotor. The plunger slide is removably coupled to the piston. The pistoncomprises a first member and a second member. The first member has anexternal proximate side and an external distal side. The externalproximate side is adapted to contact the fluid and is made of a materialhaving a first stiffness. The second member has a first side and asecond side and is at least partially disposed within the first member.The first side of the second member is adjacent to the externalproximate side of the first member and is made of a material having astiffness which is greater than the first stiffness.”

International Patent Application Publication No. WO/2011/090956 by theinstant applicant (Cabiri) and/or U.S. Patent Application PublicationNo. 2009/0093792 to Gross.

Additional background art includes U.S. Patent Application Publication20130304021, U.S. Patent Application Publication 20130296799, U.S.Patent Application Publication 20130245596, U.S. Pat. No. 8,465,455,International Patent Application Publication No. WO/2011/090956 and U.S.Patent Application Publication No. 2009/0093792.

BRIEF SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the invention, there isprovided an assembly for driving a stopper in a drug reservoir of a drugdelivery device comprising: a telescoping assembly that telescopes byrelative rotation between at least a proximal shaft and a distal shaftoriented along and axis of the reservoir; the distal shaft configured toengage the stopper of the drug reservoir; an anti-rotational guide sizedto move along the axis of the reservoir; the anti-rotational guideslidably and anti-rotationally coupled to a housing of the drug deliverydevice; a coupling slidably and anti-rotationally linking theanti-rotational guide to the distal shaft; the sliding and anti-rotationwith respect to the axis of the reservoir such that rotating theproximal shaft with respect to the anti-rotational guide moves thedistal shaft along the axis and moves the distal shaft with respect tothe anti-rotational guide the anti-rotational guide also moving alongthe axis.

According to some embodiments of the invention, a maximum axial movementof the distal shaft with respect to the reservoir is greater than amaximum axial movement of the guide with respect to the reservoir.

According to some embodiments of the invention, the assembly furthercomprises: an intermediate shaft threadably engaged to the proximalshaft and to the distal shaft such that the telescoping assembly alsotelescopes by rotating the proximal shaft with respect to theintermediate shaft.

According to some embodiments of the invention, a maximum axial movementof the distal shaft with respect to the reservoir is greater than amaximum axial movement of the intermediate shaft with respect to thereservoir.

According to some embodiments of the invention, the assembly furthercomprises: a linear stabilizer coupled to the proximal shaft, inhibitingaxial movement of the proximal shaft in a proximal direction withrespect to the linear stabilizer, the linear stabilizer coupled to thereservoir inhibiting axial movement of the linear stabilizer in aproximal direction with respect to the reservoir, such that the rotationof the proximal shaft causes the distal shaft to advance distally insideof the drug reservoir.

According to some embodiments of the invention, the linear stabilizerincludes a connecter shaped to attach to a proximal portion of thereservoir.

According to some embodiments of the invention, the connecter is shapedto attach to a flange of the reservoir.

According to some embodiments of the invention, the linear stabilizerincludes an anti-rotational connector fitting to the housing forpreventing rotation of the linear stabilizer with respect to the housingand wherein the anti-rotational guide slidably engages to the housing bymeans of the linear stabilizer.

According to some embodiments of the invention, the reservoir and theassembly form a cartridge and wherein the housing includes an openingfitting the cartridge and wherein the anti-rotational connector isshaped to connect to the housing to limit rotation of theanti-rotational connector with respect to the housing when the cartridgeis inserted into the opening.

According to some embodiments of the invention, the assembly furthercomprises: a bearing preventing proximal movement of the proximal shaftwith respect to the housing and allowing rotation of the proximal shaftwith respect to the housing.

According to some embodiments of the invention, the assembly furthercomprises a stopper interface for driving the stopper; the interface isoptionally connected to the distal shaft.

According to some embodiments of the invention, the coupling includes aprotrusion slidably inserted into a track.

According to an aspect of some embodiments of the invention, there isprovided a method of supplying a drug to a delivery device comprising:providing a reservoir containing a drug and sealed with a stopper and atelescoping assembly that telescopes by rotating a proximal shaft withrespect to a distal shaft; the distal shaft configured to engage thestopper; slidably and anti-rotationally engaging an anti-rotationalguide to a housing of the delivery device; preventing rotation of thedistal shaft with respect to the housing by slidably guiding the distalshaft along the anti-rotational guide, and extending the distal shaftand the anti-rotational guide linearly inside a cavity of the reservoirtoward a distal end of the reservoir by rotating the proximal shaftwherein a distance of the extending of the distal shaft is greater thana distance of the extending of the anti-rotational guide.

According to some embodiments of the invention, the method furtherincludes: driving the rotating of the proximal shaft with a motor of thedrug delivery device.

According to some embodiments of the invention, the distal shaft isinitially distanced proximally from the stopper and the extending istoward the stopper.

According to some embodiments of the invention, the distal shaft abutsagainst the stopper and further comprising driving the stopper insidethe cavity toward the distal end of the reservoir by the extending ofthe distal shaft.

According to some embodiments of the invention, the method furthercomprises: attaching a linear stabilizer to the reservoir and inhibitingproximal movement of the proximal shaft with respect to the linearstabilizer.

According to some embodiments of the invention, the method furthercomprises: forming a cartridge including the reservoir, the stopper, thedistal shaft, the anti-rotational guide, and the linear stabilizer andinserting the cartridge as a single unit into the drug delivery device.

According to some embodiments of the invention, the method furthercomprises: coupling the housing to the proximal shaft and inhibitingproximal movement of the proximal shaft with respect to the housing.

According to some embodiments of the invention, the preventing includesinserting a protrusion into a track.

According to some embodiments of the invention, the inserting includeselastically deforming at least one of the distal shaft and theanti-rotational guide.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1A is a block diagram of a stopper driver in accordance with anembodiment of the present invention;

FIG. 1B is a block diagrams of a cartridge inserted into a drug deliverydevice in accordance with an embodiment of the present invention;

FIG. 2 is a flow chart illustrating a method of driving a stopper inaccordance with an embodiment of the present invention;

FIG. 3 is a flow chart illustrating a method of assembling a stopperdriver in accordance with an embodiment of the present invention;

FIG. 4A is an exploded view of a reservoir and a stopper driverincluding sliding sleeve anti-rotational guides in accordance with anembodiment of the present invention;

FIG. 4B is cross sectional view of a stopper driver including slidingsleeves in an extended configuration in accordance with an embodiment ofthe present invention;

FIG. 4C is a perspective view of a reservoir and a stopper driverincluding sliding sleeves in an retracted configuration in accordancewith an embodiment of the present invention;

FIG. 4D is a perspective view of insertion of a cartridge including astopper driver and a reservoir into a drug delivery device in accordancewith an embodiment of the present invention;

FIG. 4E is a perspective view of a linkage between a cartridge and amotor of a drug delivery device in accordance with an embodiment of thepresent invention;

FIG. 5A is a perspective view of a stopper driver including sliding postanti-rotational guides in a retracted configuration in accordance withan embodiment of the present invention;

FIG. 5B is a cross sectional view of a stopper driver including slidingpost anti-rotational guides in an extended configuration in accordancewith an embodiment of the present invention;

FIG. 6A is a close up cross sectional view of a stopper driverstabilized by a device housing in a retracted configuration inaccordance with an embodiment of the present invention;

FIG. 6B is a cross sectional view of a reservoir and a stopper driverstabilized by a device housing in a retracted configuration inaccordance with an embodiment of the present invention; and

FIG. 6C is a cross sectional view of a reservoir and a stopper driverstabilized by a device housing in a retracted configuration inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention, in some embodiments thereof, relates to a stopperdriver for a drug delivery device and, more particularly, but notexclusively, to a telescoping stopper driver of a drug cartridge.

Overview

An aspect of some embodiments of the present invention relates to ananti-rotational guide for stopper driving assembly of a drug deliverydevice. Optionally, a distal shaft of the driver assembly is heldrotationally stationary by the guide while being driven distally intothe reservoir by relative rotation of a rotating proximal element. Asthe distal element progresses distally into the reservoir, the shaft mayslide distally with respect to the guide. Additionally or alternatively,the guide and shaft may slide together distally into the reservoir. Insome embodiment, the proximal element and the distal shaft may telescopewhen rotated in relation to one another. The proximal element may beheld axially immobile with respect to the reservoir such that thetelescoping of the proximal and distal elements forces the distal shaftinto the reservoir.

Some embodiments may include a linear and/or a rotational stabilizer.For example a rotational stabilizer may be supported by a housing of thedrug delivery device and/or a motor mount such that torque on thetelescoping assembly is balanced against the anti-rotational guideand/or the motor and/or the housing of the delivery device. Optionallythe torque will not be applied to the drug reservoir and/or the stopperand/or any part that is in contact with the drug.

In some embodiments, a linear force between the stopper and the driverassembly is balanced against the reservoir. Optionally the linear stressbetween the pushing assembly and the stopper is balanced with negligibleor no external linear stresses on the drug delivery device and/orbetween the reservoir and the drug delivery device.

In some embodiments, the driver assembly may be attached to a drugreservoir to form a cartridge. The entire cartridge is optionallyinserted as a unit into the drug delivery device. In some embodiments,the cartridge may meter out a drug while producing negligible or noexternal axial forces on the drug delivery device. For example, thecartridge assembly may include a linear stabilizer connecting the TSA tothe drug reservoir. For example, the linear stabilizer may connect tothe reservoir near a proximal opening of the reservoir and/or on aproximal flange thereof. Optionally, linear forces between a stopper andthe TSA may be balanced by forces between the linear stabilizer and thereservoir. Optionally, the entire cartridge assembly is inserted into aproximal opening in a drug delivery device. Optionally when thecartridge is inserted into the proximal opening of the drug deliverydevice, a cannula pierces a septum creating a fluid path between thereservoir and the drug delivery device. For example the septum may belocated on and/or near the distal end of the cartridge. Alternatively oradditionally example the septum may be located on and/or near the distalportion of the drug delivery device.

In some embodiments a cartridge pushing assembly may be attached to aproximal opening of a reservoir without regard to the preciselongitudinal position of a stopper in the reservoir. Optionally, afterconnecting the stopper pushing assembly to the reservoir, the TSA may beextended until the pushing assembly contacts the stopper. For example,the TSA may be extended before inserting the cartridge assembly into adrug device. Alternatively or additionally, The TSA may be extendedafter inserting the cartridge assembly into the drug delivery device.

In some embodiments, the stroke length of the TSA may be greater thanthe minimum length of the TSA. For example a TSA may have threetelescoping shafts and/or three telescoping guides. For example atelescoping shaft may include an extension rod. Alternatively oradditionally a TSA may have four telescoping shafts and/or fourtelescoping guides. Alternatively or additionally a TSA may have fivetelescoping shafts and/or five telescoping guides. For example a TSA mayhave a contracted configuration with length ranging between 0.8 and 1.6cm and/or an extended configuration with length ranging between 2.0 to4.0 cm. Optionally, the extended length of the TSA may range between 2.0to 3.0 times the contracted length and/or between 3.0 to 5.0 times thecontracted length.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Cartridge Assembly

Referring now to the drawings, FIG. 1A is a block diagram of a stopperdriving assembly 150 in accordance with an embodiment of the presentinvention. Driving assembly 150 optionally includes a linear stabilizer106 supporting a driver assembly 150 and/or balancing linear forcesbetween driver assembly 150 and a stopper (for example stopper 140 ofFIG. 1B). Driver assembly 150 optionally includes an anti-rotationalguide, for example guide 104. Anti-rotational guide 104 optionallysupports the driver assembly and/or balances torque between the driverassembly and a motor (for example motor 108 of FIG. 1B).

In some embodiments, stopper driver assembly 150 may include atelescoping assembly (for example TSA 152). Optionally, TSA 152 includesa proximal shaft, for example a threaded drive shaft 110 and/or athreaded mid shaft 112 and/or a distal shaft, for example a threadedpushing shaft 114. Shafts 110, 112 and/or 114 may be coupled such thatrotating drive shaft 110 with respect to pushing shaft 114 causes TSA152 to lengthen and/or shorten. Optionally axial movement of drive shaft110 is limited by linear stabilizer 106 such that rotating drive shaft110 with respect to pushing shaft 114 causes pushing shaft 114 to movelinearly with respect to linear stabilizer 106. Optionally, a couplinglinks pushing shaft 114 to anti-rotational guide 104. For example,rotation of pushing shaft 114 may be limited by anti-rotational guide104 such that rotating drive shaft 110 with respect to anti-rotationalguide 104 causes TSA 152 to lengthen and/or shorten. Alternatively oradditionally, drive shaft 110 and/or pushing shaft 114 may be replacedby a nut and/or threaded disk and/or ring.

FIG. 1B is a block diagram of a cartridge 153 inserted into a drugdelivery device 122 in accordance with an embodiments of the presentinvention. Optionally, cartridge 153 includes driving assembly 150, adrug reservoir 120 and/or a stopper 140. Optionally drug delivery device122 includes a motor 108. Alternatively or additionally motor 108 mayinclude a DC electric motor, a chemical engine, a brushless motor, andAC motor, an actuator etc.

In some embodiments, linear stabilizer 106 may be attached to drugreservoir 120 and/or pushing shaft 114 may abut against stopper 140 suchthat extending TSA 152 moves stopper 140 axially with respect toreservoir 120. Axial back forces of stopper 140 with respect toreservoir 120 (for example due to friction between stopper and reservoirand/or due to flow resistance) are optionally balanced within cartridge153 by a linear force between linear stabilizer 106 and reservoir 120.

In some embodiments, motor 108 may apply a torque to drive shaft 110.Optionally, anti-rotational guide 104 may be attached to drug reservoir120 such that activating motor 108 moves pushing shaft 114 axially withrespect to drive shaft 110. Friction between driving shaft 110 andpushing shaft 114 are optionally balanced by an anti-torque betweenmotor 108 and anti-rotational guide 104 such that TSA 152 acts as alinear actuator putting a net linear force (and/or a negligible torque)on the parts of the device that are in contact with the drug (forexample stopper 140 and/or reservoir 120).

In some embodiments, any or all of linear stabilizer 106, drive shaft110, mid shaft 112, pushing shaft 114 and/or anti-rotational guide 104may be partially and/or wholly located inside reservoir 120.Alternatively or additionally, any or all of linear stabilizer 106,drive shaft 110, mid shaft 112, pushing shaft 114 and/or anti-rotationalguide 104 may be wholly or partially located outside reservoir 120 whenTSA 152 is contracted and/or may move wholly or partially into reservoir120 when TSA 152 expands.

In some embodiments, mid-shaft 112 and/or anti-rotational guide 104 maymove axially. For example mid-shaft 112 and/or anti-rotational guide 104may move into and/or out of reservoir 120. Optionally mid-shaft 112 mayfloat. In the current disclosure, in some configurations (for examplewhen TSA 152 is partially extended) the position of a floating part maybe indeterminate. For example the part may move without changing thelength of TSA 152. For example the order of movement of parts of TSA 152may be not fixed. Optionally, driver shaft 110 may be an inner shaft andthe pushing shaft 114 may be an outer shaft. Alternatively oradditionally driver shaft 110 may be an outer shaft and the pushingshaft 114 may be an inner shaft. Any or all of the components of thecurrent invention may be made of plastic and/or metal and/or anothermaterial.

Driving a Stopper

FIG. 2 is a flow chart illustrating a method of driving a stopper inaccordance with an embodiment of the present invention. In someembodiments, a TSA may be extended or retracted by more than 100% itsminimum length by rotating 210 a single shaft and/or by inhibitingrotation of a single shaft. For example, a TSA may be opened by rotating210 a drive shaft. Optionally a proximal drive shaft may be locatedproximally to a distal pushing shaft. For example, the drive shaft maybe rotated 210 with respect to a drug delivery device by a motor mountedon the device. For example rotation 210 of the drive shaft may be withrespect to the housing of the drug delivery device and/or with respectto a mount of the motor. Optionally, while the drive shaft is rotating,a pushing shaft may be inhibited 202 from rotating. For example, ananti-rotational guide may prevent the pushing shaft from rotating withrespect to the drug delivery device housing and/or with respect to themotor and/or with respect to a motor mount. Rotating 210 the drive shaftwith respect to the pushing shaft optionally extends the TSA and/or thepushing shaft and/or a stopper.

In some embodiments, the mid shaft may axially float. For example, whenthe TSA is extended the mid shaft may either extend linearly 212 withthe pushing shaft and/or rotate 213 with the drive shaft. Optionally,for some lengths of the TSA, the position of the mid shaft may beindeterminate. For example, rotating 210 the drive shaft may, forexample, extend 212 a mid-shaft into a reservoir (for example when thedrive shaft rotates faster than the mid-shaft and/or by means ofthreading coupling the drive shaft to the mid shaft). Optionally,extending 212 the mid-shaft into the reservoir simultaneously extends214 the pushing shaft into the reservoir. Alternatively or additionally,rotating 210 the drive shaft may rotate 213 the mid-shaft. Optionally,rotating 213 the mid-shaft extends 214 a pushing shaft into thereservoir (for example by means of threading coupling the drive shaft tothe mid shaft). Rotation and/or extension of the mid shaft may occurconcurrently and/or sequentially.

In some embodiments, the anti-rotational guide may axially float. Forexample, when the TSA is extended the anti-rotational guide may eitherextend 204 (for example moving axially with respect to and/or into thereservoir) along with the pushing shaft and/or the anti-rotational guidemay remain stationary with respect to the reservoir and/or the pushingshaft may extend 214 axially with respect to the anti-rotational guide.Optionally, for some lengths of the TSA, the position of theanti-rotational guide may be indeterminate. In some embodiments, apushing shaft may rotate while another element of the TSA isanti-rotationally stabilized (inhibited from rotating with respect forexample to a drug delivery device housing and/or a motor).

Assembly and/or Installation of a Stopper Driver

FIG. 3 is a flow chart illustrating a method of assembling a stopperdriver in accordance with an embodiment of the present invention. Forexample the stopper driver, may fit a reservoir fillable with standardpharmaceutical equipment (for example in an existing clean room withfilling equipment made for a standard syringe and/or cartridge).Optionally, the stopper driver engages the stopper located at anarbitrary position within the reservoir. In some embodiments the stopperdriver may be assembled with snap together parts. The parts areoptionally made of molded materials such as plastic, for examplepolyoxymethylene (POM) resin.

In some embodiments a drug reservoir is supplied 320. Optionally thereservoir may be prefilled. For example, the reservoir may be filledusing standard filling equipment. For example, the reservoir may have acylindrical and/or tubular body of arbitrary cross section. For examplethe body may be in the form of a right circular cylinder. The reservoiroptionally includes an internal cavity. Optionally, the internal cavitymay be of arbitrary shape. For example, the internal cavity may have asmooth wall over at least half its length and/or over at least 90% ofits length. For example the cavity of the reservoir may be substantiallya right circular cylinder over at least half its length and/or over atleast 90% of its length. For example the internal cavity may be coaxialwith the outer walls of the reservoir over at least half its lengthand/or over at least 90% of its length. For example the cross section ofthe cavity may be uniform over at least half its length and/or over atleast 90% of its length. Optionally the reservoir may include a distalopening. For example the distal end of the reservoir may include cannulafor example a hypodermic needle and/or a mount for such. Alternativelyor additionally the distal end of the reservoir and/or the distalopening may include a seal, for example a septum and/or sterile coverfor example a needle cover. The proximal end of the reservoir mayinclude a proximal opening. Optionally the proximal opening may belarger than the distal opening. For example the cross sectional area ofthe proximal opening may range between 5 to 50 times the cross sectionalarea of the distal opening and/or 50 to 500 times the cross sectionalarea of the distal opening. Optionally the cross sectional opening maybe beveled and/or may smoothly connect to the internal cavity of thereservoir. Optionally, a stopper may be inserted into the proximalopening. Optionally the stopper may seal and/or preserve sterility ofthe contents of the reservoir. Optionally the position of the stoppermay vary dependent on the volume of the contents of the reservoir.Optionally the proximal end of the reservoir may include a flange. Forexample the flange may extend from the between 20% to 100% of theperimeter of the reservoir. For example the flange may extend between 1mm and 2 cm from the internal walls of the proximal opening. Optionallythe reservoir may be made as a single integral unit for example ofmolded glass or plastic and/or cut and/or processed tubing.

In some embodiments a TSA is assembled in a simple manner. Optionally,assembly may be unidirectional. Unidirectional assembly may include, forexample, insertion of all or most shafts from the same end of the TSA.Unidirectional assembly may include, for example, threading some mostand/or all shafts in the same direction. Optionally, assembly may beaccomplished without reversing orientation of the parts during assemblyand/or adding without other complimentary work such as welding,riveting, plastic deformation etc.

In some embodiments, a series of shafts may be threaded together. Forexample for a leading end of an interior shaft may be inserted through arear (distal) end of a more exterior shaft. For example a leading end ofan interior shaft may be threaded into a more exterior shaft and/or adistal end of the more exterior shaft. As used herein, the term/phraseleading end means the end of a TSA from which the inner shaft projectsin the extended state. As used herein, the term/phrase rear end meansthe end of a TSA from which the outer shaft projects in the extendedstate. As used herein, the term/phrase threading means screwing the moreinterior shaft towards the leading direction (in some embodimentsthreading is used to assemble and/or extend the TSA). As used herein,the term/phrase de-threading means screwing the more interior shafttowards the rear of the outer shaft (in some embodiments dethreading isused to contract the TSA). Alternatively or additionally, in someembodiments dethreading may be used to assemble and/or extend the TSAand/or threading may be used to contract the TSA. Optionally, theleading end of the most inner shaft may include a fastener and/or therear end of the most external shaft may include a fastener.

In some embodiments of the invention a TSA resists disengagement and/ordetaching of shafts upon extension. For example, an internal shaft ofthe TSA may include a flange and/or a step on its rear end. The flangemay prevent disengagement from a more outer shaft. Alternatively oradditional the flange may be replaced by a protrusion of a differentgeometry.

In some embodiments, a TSA may be simple assembled unidirectionally froma reverse extended position. The assembled TSA may optionally resistdis-assembly by extension.

In some embodiments a TSA is assembled from molded parts. In someembodiments, molding provides highly precise part geometries. Moldedparts may optionally be assembled with minimal modifications duringassembly. For example, the assembly of the TSA may be include minimal orno adhesion of parts, and/or changing of part geometries by heat and/orultrasonic means and/or by force (for example by crimping). The moldedparts may optionally include features to facilitate proper orientation.The molded parts may optionally include built in connectors and/orfasteners (for example snaps, latches, catches, hooks, clasps and thelike). In some embodiments that parts may be molded of plastic. Forexample plastic may include low friction materials. Examples of suchmaterials include a Polybutylene terephthalate (PBT) resin (for exampleCELANEX® resin available from TICONA) and/or a POM resin (for exampleDelrin® resin DuPont™).

In some embodiments an internal shaft may be molded in a single piecewith the rear flange and/or projections. The flange and/or projectionmay optionally impede unintentional disengagement of the shaft. In someembodiments a part may be molded in a single piece with a fastener. Insome embodiments a part may be molded in a single piece with a threadstopper and/or an interference element.

In some embodiments, some or all of the shafts of the assembly mayoptionally be supplied disassembled from an end cap. For example, thesome or all of the shafts and/or end caps may include fasteners. Theshafts may optionally be supplied with flanges inhibiting disassemblydue to overextension. For example, an internal shaft may have a flangeon a rear end. The flanges and/or fasteners may optionally be intrinsic.For example, the shafts and/or caps may be molded in a single piece withthe fasteners and/or flanges.

In some embodiments, some or all of the shafts may be assembled togetherby reverse extension. For example, a leading end of an internal shaftmay be inserted into a rear end of a more external shaft. For example,the internal shaft may be threaded from a disassembled (reverseextended) position through its contracted position out the leading endof a mating shaft to an extended position. In some embodiments, flangeswhich prevent the shafts from disattaching in the extended state mayalso prevent attaching the shafts from the extended state and threadingthem to the contracted state.

In some embodiments, a fastener may be supplied on a leading end of aninner shaft. Once the leading end of an inner shaft extends beyond themating shaft, an end cap (for example a driver and/or an actuator) maybe fastened to the fastener. Optionally an interference element may besupplied. For example the interference element may include a flange thatblocks dethreading back to the reverse extended position and/or mayinclude one or more protrusions that prevent thread lock resulting fromcollision between a shaft and an end cap.

Referring now to FIG. 3, the figure illustrates an exemplary method forassembling a TSA. In some embodiments, the leading end of an inner shaft(for example drive shaft 410 illustrated of FIG. 4A) may be threaded 310into the rear end of a mid shaft (for example mid shaft 412 of FIG. 4A).Optionally the leading end of the inner shaft may be threaded all theway through a mid shaft until the leading end of the inner shaftprotrudes from the leading end of the mid shaft.

In some embodiments, the leading end of the mid shaft along with theinner shaft may be threaded 312 into a rear end of a distal outer shaft(for example pushing shaft 414 of FIG. 4A). Threading 312 may continueuntil the leading end of the inner shaft protrudes out the leading endof the outer shaft. Optionally, the assembly may include only two shaftsand/or three shafts and/or more than three shafts (for example four,five, six or more shafts). In some embodiments, regardless of the numberof shafts, the assembly of shafts may have a fastener of the inner shaftprotruding from the leading end and a fastener of an outer shaftprotruding from the rear end.

In some embodiments, an actuator cap (for example distal cap 424 of FIG.4A) may be attached 324 to the fastener of the outer shaft. For example,an actuator cap may include a syringe stopper and/or a fitting to attachto a syringe stopper. Examples of syringe stoppers actuated bytelescopic assemblies can be found for example in International PatentApplication Publication No. WO/2011/090956 to Cabiri and/or U.S. PatentApplication Publication No. 2009/0093792 to Gross which are hereinincorporated in their entirety by reference.

In some embodiments, an outer shaft may be connected 304 to a firstanti-rotational guide (for example anti-rotational guide 404 of FIG.4A). For example the first guide and the outer shaft may move axiallywith respect to each other, but may be inhibited from rotation withrespect to each other around the axis. Optionally the first guide may beconnected 302 to a second guide (for example stabilizer 402 of FIG. 4A).For example the second guide and the first guide may move axially withrespect to each other, but may be inhibited for rotating with respect toone another around the axis. The linear stabilizer in some embodimentsis also an anti-rotational stabilizer. In some embodiments, the firstanti-rotational guide and the second anti-rotational guide may becollapsed such that the proximal end of the drive shaft protrudes beyondthe proximal ends of the guides. The proximal end of the drive shaft maybe connected to a transmission. For example, the proximal end of driveshaft 410 may be inserted 326 through a slot in a gear (for exampleconnector 432 a of drive shaft 410 may be inserted into slot 432 b of acartridge gear 426 of FIG. 4A). Optionally, the proximal end of theassembly will be held together 327 by a proximal end cap (for example anend cap 438 may snap to a retainer 437 which may hold to a fastener 430on the proximal end of drive shaft 410 in FIG. 4A).

In some embodiments, after assembly, the TSA may be contracted and/orrewound 328 (for example by dethreading) to a stop position. Optionally,the TSA may include one or more thread stoppers. For example, a threadstopper may include an interference element and/or a protrusion on arotating shaft (for example mid shaft 412 and/or drive shaft 410) and/oron an end cap (for example actuator cap 424). One or more interferenceelements may meet at a predefined point in the contraction of the TSAand prevent further relative rotation. For example, the interferenceelements may prevent rotation in the dethreading direction of the innershaft with respect to the outer shaft thereby inhibiting furthercontraction and/or thread lock (for example see interference elements436 and 434 of FIG. 4A).

In some embodiments a stopper driver is attached to a drug reservoir toform a cartridge. For example, a linear stabilizer (for examplestabilizer 402) may be attached to the reservoir (for example,connectors 421 a may be attached to flange 421 b as illustrated in FIGS.4A and 4C). A connector that inhibits linear movement of linearstabilizer may be called a linear connector. For example linearconnector 421 a inhibits linear movement of stabilizer 402 with respectto cartridge 420. Alternatively or additionally, the stopper driverand/or the linear stabilizer may be attached to the housing of a drugdelivery device (for example as illustrated in FIGS. 6A-6C).

In some embodiments before inserting the cartridge into a drug deliverydevice, the TSA may be extended 314 to contact the stopper in thereservoir. Contacting the stopper with the TSA before engaging the TSAto the delivery device may make it easy to determine the volume of druginjected (based on the distance that the stopper has moved which may beproportional to the number of revolutions of the motor and/or driveshaft [for example the pitch of the threading on all of the shafts maybe adjusted so that the ratio of revolutions to volume discharged isconstant]). Alternatively or additionally, in some embodiments, thereservoir and/or the stopper driver and/or a complete cartridge may beinserted into a drug delivery device before the TSA has contacted thestopper. For example the motor of the drug delivery device may firstdrive the drive shaft to expand 314 the TSA until it contacts thestopper and then continue to drive the drive shaft to discharge thedrug. Allowing the TSA to not contact the stopper until after insertionin the drug delivery device optionally simplifies production and orshipping of the cartridge. In some embodiments, the drug delivery devicemay deliver the entire content of the cartridge without tracking thequantity delivered. For example in some cases a cartridge may includeexactly one dose. In some embodiments, the drug delivery device mayinclude a sensor (for example a load sensor) that senses when the TSA isexpanding 314 toward the stopper and/or when the TSA engages the stopperand/or when the TSA is pushing the stopper against a resistance (forexample discharging the drug). Alternatively or additionally, thestopper may be placed into the reservoir in an exact position such thatthe TSA contacts the stopper exactly upon installation. For example itmay be unnecessary to expand 314 the TSA after installation to contactthe stopper.

In some embodiments, an anti-rotational guide is attached 322 to ahousing of the drug delivery device. For example, in FIG. 4D when thecartridge is inserted into the device, connectors 421 a fit into slots421 c preventing rotation of stabilizer 402 with respect to a housing ofa drug delivery device 422 and/or a motor 408 (for example see FIG. 4E)attached thereto. In some embodiments when cartridge 453 is insertedinto delivery device 422, housing 422 may engage the cartridge. Forexample interference elements 439 may snap to cartridge 453 and/orretain cartridge 453 in the delivery devices. Alternatively oradditionally, an anti-rotational guide may be attached to the reservoirand/or the reservoir may be attached to the housing and/or motor of thedelivery device. A connector that inhibits rotational movement of ananti-rotational stabilizer may be called an anti-rotational connector.For example anti-rotational connector 421 a inhibits rotational movementof stabilizer 402 with respect to the housing deliver device 422.

A Stopper Driver with Sliding Sleeve Anti-Rotational Guide

Referring now to FIG. 4A, the figure is an exploded illustration of anembodiment of a reservoir and a stopper driver including sliding sleevesin a reverse extended state. In some embodiments a reservoir 420 issupplied sealed with a stopper 440. Optionally reservoir 420 isprefilled and/or stopper 440 is sealed in place using standard fillingequipment. In some embodiments, a stopper driver 450 may be assembledfrom simple and/or snap together parts.

In some embodiments a reservoir 420 may include a proximal opening 454,and/or a distal opening 456. Stopper 440 optionally seals the cavity ofreservoir 420. Optionally the stopper may be placed at an arbitrarylongitudinal position depending on, for example the volume of the drugdistal to stopper 440 and/or space needed for the contracted stopperdriver proximal to stopper 440.

In some embodiments, reservoir 420 may include a distal opening 456and/or a proximal opening 454. For example, proximal opening 454 may belarge enough to insert stopper 440. Optionally, distal opening may beconfigured with a neck and/or a mount for a needle and/or a septum.

In some embodiments, stopper driver 450 includes a TSA 452. TSA 452 isoptionally assembled from the reverse expanded state (e.g. asillustrated in FIG. 4A). For example, the proximal end of drive shaft410 is inserted into mid-shaft 412 until external screw threads 411 a ofdrive shaft 410 engage internal threads 411 b near the proximal end ofmid shaft 412. Optionally drive shaft 410 is threaded through mid shaft412 until the proximal end of drive shaft 410 projects out the proximalend of mid shaft 412. Optionally, the proximal end of the combinedassembled mid shaft 412 and/or drive shaft 410 is inserted into pushingshaft 414 until external screw threads 413 a of mid shaft 412 engageinternal threads 413 b near the proximal end of pushing shaft 414.Optionally mid shaft 412 is threaded through pushing shaft 414 until theproximal end of drive shaft 410 projects out the proximal end of pushingshaft 414. Optionally a locking and/or snap element prevents TSA 452from becoming disassembled. For example, a distal cap 424 may include aninterference element which locks (e.g. snap fits) to a constrainingelement, for example a hole in pushing shaft. Alternatively oradditionally distal cap 424 may prevent de-threading of the TSA 452. Forexample, once distal cap 424 is in place, when drive shaft 410 isde-threaded from mid-shaft 412, a receptor on distal cap 424 blocksfurther movement by a matching interference element thread lockprotector on pushing shaft 414 inhibiting further de-threading. Forexample once distal cap 424 is in place, when mid shaft 412 isde-threaded from pushing shaft 414, an interference element thread lockprotector interference element 436 on the distal end of mid shaft 412 isblocked by a matching interference element on distal cap 424 inhibitingfurther de-threading. Optionally, a TSA may include more than threeshafts. For example there may be more than 1 mid shaft. In someembodiments drive shaft 410 may be an inner shaft and pushing shaft 414may be an outer shaft. Optionally or additionally a drive shaft may bean outer shaft and a pushing shaft may be an inner shaft. In someembodiments, the assembled TSA 452 is assembled into a stopper driver450.

In some embodiments, TSA 452 is engaged to an anti-rotational guideand/or a transmission element. For example, a coupling including aprojection 415 a engaged to a track 415 b may link pushing shaft 414 toan anti-rotational guide 404. Anti-rotational guide is optionallyengaged to a stabilizer 402. For example, a projection 405 a ofanti-rotational guide 404 may be engaged to a track 405 b (for examplesee FIG. 4B) in stabilizer 402. Optionally, pushing shaft 414,anti-rotational guide 404 and/or stabilizer 402 are slidably engaged.For example, pushing shaft 414, anti-rotational guide 404 and/orstabilizer 402 may slide axially with respect to each other, but areinhibited from rotating one with respect to the other around the axis.In some embodiments, guide elements may snap together. For example,track 415 b and/or track 405 b may include an interference element (forexample at a distal end thereof and/or at a proximal end thereof).Projection 415 a is optionally inserted over the distal interferenceelement into track 415 b by elastically deforming anti-rotational guide404 as projection 415 a is inserted. Once projection 415 a is insidetrack 415 b, anti-rotational guide 404 optionally returns to itsoriginal shape and/or projection 415 a is inhibited from exiting track415 b by the interference element. Alternatively or additionally,pushing shaft 414 may be elastically squeezed to retract projections 415a at they are fit into track 415 b. Projection 405 a is optionallyinserted over the distal interference element into track 405 b byelastically deforming anti-stabilizer 402 as projection 405 a isinserted. Once projection 405 a is inside track 405 b, stabilizer 402optionally returns to its original shape and/or projection 405 a isinhibited from exiting track 405 b by the interference element.Alternatively or additionally, rotational guide 404 may be elasticallysqueezed to retract projections 405 a at they are fit into track 405 b.

In some embodiments, once TSA 452 is connected its anti-rotationalguides (for example anti-rotational guide 404 and/or stabilizer 402) theguides are slid together and/or collapsed such that the proximal end ofdrive shaft 410 projects out of a proximal opening 403 in stabilizer 402and/or until a coupler (for example a shoulder bearing 406) of driveshaft 410 rests against stabilizer 402. Optionally, drive shaft 410rotates freely inside of opening 403. Optionally the transmissionelement includes for example a cartridge gear 426. The transmissionelement is optionally engaged to the projecting proximal portion ofdrive shaft 410. For example, a non-rotational fitting 432 a may beinserted through a slot and/or a receptor 432 b of cartridge gear 426such that drive shaft 410 is firmly engaged and/or aligned to gear 426and/or rotates with gear 426. Optionally a fastener and/or a snapelement prevent disassembly of stopper driver 450. For example an endcap 438 may snap to a retainer 437 which may hold to a fastener 430 onthe proximal end of drive shaft 410 in FIG. 4A. In some embodiments, theassembled stopper driver 450 is rewound for example by rotating gear 426with respect to stabilizer 402 and/or drive shaft 410 is rotated withrespect to pushing shaft 414. Optionally rotation is in a direction tode-thread TSA 452 until it has contracted and/or until de-threading isstopped by thread stopping elements. The contracted stopper driver 450is optionally attached to reservoir 420 to form a cartridge 453 (forexample see FIG. 4C).

Referring now to FIG. 4B, the figure is a cross sectional illustrationof an embodiment of stopper driver 450 in an extended state. Forexample, after assembly of stopper driver 450, cartridge gear 426 isrotated with respect to stabilizer 402 and/or drive shaft 410 is rotatedwith respect to pushing shaft 414. Optionally rotation is in a directionto thread drive shaft 410 and/or mid shaft 412 proximally through theproximal end of pushing shaft 414 thereby expanding TSA 452 into anextended configuration, for example as illustrated in FIG. 4B.

In some embodiments a shaft may include a member to preventdisengagement of the shaft during over threading and/or over extensionof the TSA. For example drive shaft 410 includes a rear flange 482 andmid shaft 412 includes a rear flange 484. When shaft 410 reaches fullextension, flange 482 optionally contacts interior threads 411 b of midshaft 412 preventing further extension. When shaft 412 reaches fullextension, flange 484 optionally contacts interior threads 413 b ofpushing shaft 414 preventing further extension. Alternatively oradditionally an element to prevent disengagement of shafts due to overextension (for example flange 482 and/or 484). Optionally the elementpreventing over extension may include an interference element and/or aprotrusion and/or another element of any geometry for example an annularelement.

In some embodiments, a linear stabilizer will block movement of a driveshaft in a proximal direction. For example, shoulder bearing 406 issupported against stabilizer 402. Optionally, drive shaft 410 can rotatewith respect to stabilizer 402 around the longitudinal axis of stopperdriver 450 but is inhibited from moving axially in a proximal directionwith respect to stabilizer 402.

FIG. 4C is a perspective view of a cartridge 453 including reservoir420, stopper 440 and/or stopper driver 450 in accordance with anembodiment of the present invention. In some embodiments, the assembledstopper driver 450 may be attached to reservoir 420. For example,connectors 421 a may clip stabilizer 402 onto rear flange 421 b ofreservoir 420. Optionally, stabilizer 402 is a linear stabilizerlinearly stabilizing and/or retaining TSA 452 inside the cavity ofreservoir 420 and/or inhibiting proximal movement of driver 410 (forexample by means of shoulder bearing 406 as illustrated in FIG. 4B).When TSA 452 is expanded pusher shaft 414 moves distally with respect tostabilizer 402 and/or reservoir 420 until pusher shaft 414 contactsstopper 440. Further expansion of TSA 452 pushes stopper 440 distallyand/or discharges the drug.

In some embodiments, Cartridge 453 is inserted as a single element intoa drug delivery device. Optionally, when stopper driver 450 is installedto cartridge 453 in a contracted state, a large portion of driver 450(for example ranging between 50% to 75% and/or ranging between 75% to90% and/or ranging between 90% to 100%) is positioned inside reservoir420. Alternatively or additionally most or all of the stopper driver maybe on the outside of the reservoir when the driver is in a contractedstate and/or when the driver is attached to the reservoir.

FIG. 4D is a perspective view of insertion of cartridge 453 into a drugdelivery device 422 in accordance with an embodiment of the presentinvention. In some embodiments, inserting a cartridge into drug deliverydevice 422 will open a fluid flow path between reservoir 420 and device422 and/or engage a transmission element of cartridge 453 to a motor ofdevice 422 and/or rotationally stabilize the cartridge. For example,cartridge 453 is inserted linearly into a guide path in device 422. Ascartridge 453 is inserted, a cannula inside device 422 pierces a septumon the distal end of cartridge 453 creating a fluid path between device422 and reservoir 420. Alternatively or additional, a cannula on thedistal end of cartridge 453 may pierce a septum of device 422 formingthe fluid path. Alternatively or additional, a hypodermic needle on thedistal end of cartridge 453 be inserted directly into a subject.

In some embodiments, linear stabilizer 402 (as explained above) is alsoan anti-rotational stabilizer 402. Optionally, stabilizer 402 connectsdirectly to device 422 to compensate for torque applied by a motor 408to cartridge gear 426 without applying significant torque to reservoir420. For example, connectors 421 a of stabilizer 402 fit into slots 421c in drug delivery device 422. Slots 421 c prevent stabilizer 402 fromrotating with respect to device 422. Slots 421 c are angled to leadconnectors 421 a and/or rotationally align cartridge 453. For examplecartridge 453 may be inserted into device 422 without require angularalignment by the operator. Alternatively or additionally a cartridge mayhave a specific insertion alignment. In some embodiments, a linearstabilizer may be separate from an anti-rotational stabilizer.

FIG. 4E is a perspective view of a linkage between a stopper driver anda motor of a drug delivery device in accordance with an embodiment ofthe present invention. As cartridge 453 is inserted into drug deliverydevice 422, gear 426 optionally slides into engagement and/or mesheswith a transmission 474 (for example including a drive gear 473).Transmission 474 and/or drive gear 473 are optionally driven by a motor408. In some embodiments motor mounts 472 may connect motor 408 to thehousing of the drug delivery device 422. For example, as the motorapplies torque to transmission 474, the body of motor 408 isanti-rotationally stabilized against the housing of device 422 by motormounts 472. Optionally, anti-rotational torque is transferred by thehousing of device 422 and/or connectors 421 a to anti-rotationalstabilizer 402 and/or anti-rotational guide 404 and/or pushing shaft 414(for example as explained herein above).

A Stopper Driver with Sliding Post Anti-Rotational Guide

FIG. 5A is a perspective view of a stopper driver 550 including slidingpost anti-rotational guides in a retracted configuration in accordancewith an embodiment of the present invention. Optionally, ananti-rotational stabilizer 502 is connected to a stopper adapter 542 bya guide assembly including hollow guide tracks 505 b and/or slidingposts 515 a. In some embodiments, a cartridge gear 526 drives a TSA 552.Optionally connectors 521 connect anti-rotational stabilizer 502 to adrug delivery device. For example, the driver may be slid longitudinallyinto a drug delivery device. Optionally cartridge gear 526 meshes to atransmission of the device and/or connectors 521 slide into slots in thedevice. Torque is optionally supplied to gear 426 for example to extendTSA 552 and/or to push a stopper. In some embodiments, anti-rotationalstabilization is supplied to connectors 521 and/or guide elements (forexample stabilizer 502, track 505 b and/or post 515 a).

FIG. 5B is a cross sectional view of stopper driver 550 in an extendedconfiguration in accordance with an embodiment of the present invention.TSA 552 optionally includes a proximal drive shaft 410, a mid shaft 412and/or a distal stopper pushing shaft 514. For example stopper adapter542 and/or posts 515 a link pushing shaft 514 to a sliding guide post505 a and/or fixed guide track 505 b and/or stabilizer 502. Theassembled TSA 552 may optionally be held together by a distal end cap524. The anti-rotational guides of driver 550 optionally includetelescoping posts, for example an inner post 515 a may slide into ahollow mid post 505 a which may slide into a hollow track 505 b. Driveshaft 410 is optionally linearly stabilized by a coupler, for example ashoulder bearing 506. Bearing 506 optionally rest on stabilizer 502.

A Stopper Driver with Anti-Rotational Guide Stabilized by the DeviceHousing

FIG. 6A is a close up cross sectional view of a stopper driverstabilized by a device housing in a retracted configuration inaccordance with an embodiment of the present invention. In someembodiments, TSA 452 is stabilized by a housing of a drug deliverydevice 622. For example, projection 405 a of anti-rotational guide 404connects to a guide track 605 that is attached to and/or intrinsic tothe housing of device 622. Drive shaft 410 is optionally linearlystabilized against the housing of device 422. For example, linearstabilization may be via a coupler (for example a bearing 606). Forsimplicity the transmission and motor assembly are not shown in theFIGS. 6A-6C.

FIG. 6B is a perspective view of a reservoir and a stopper driverstabilized by a device housing in a retracted configuration and engagedwith stopper 440 and reservoir 620 in accordance with an embodiment ofthe present invention. For example, reservoir 620 may be shorter thanreservoir 420. In the contracted state, TSA 452 remains outside of thedistal end of reservoir 420. Optionally, in the embodiment of FIGS.6A-6C, reservoir 620 and TSA 452 are built into drug delivery device 622rather than being inserted as a cartridge into the device by a user. Thehousing of device 622 optionally includes a shoulder 621 which linearlystabilizes reservoir 620 (for example locking it in an axial positionwith respect to the housing). For simplicity, the fluid path connectingdistal opening 456 to device 622 is not shown in the FIGS. 6A-6C.

FIG. 6C is a perspective view of a reservoir and a stopper driverstabilized by a device housing in a retracted configuration inaccordance with an embodiment of the present invention. Optionally driveshaft 410 is rotated expanding TSA 452. For example TSA 452 expands intoreservoir 620 and/or pushes stopper 440 into reservoir 620 and/ordischarges a drug from reservoir 620. Optionally as TSA 452 expands, ananti-rotational guide moves into reservoir 620. For example projection405 a may slide down track 605 as anti-rotation guide 404 may slide intoreservoir 620 and/or projection 415 a may slide down track 415 b aspushing shaft 414 slides with respect to anti rotation guide 404.

Exemplary Dimensions of a Drug Delivery Device

In some embodiments the payload of a reservoir (for example a syringe)may include, for example between 0.5 and 3 ml and/or between 3 and 6 mland/or between 6 and 10 ml and/or between 10 and 15 ml of a drug and/ormore. In some embodiments, the injector may discharge the entire payloadas a single dose. A drug delivery device may include, for example, a peninjector and/or a patch injector, and/or an internally powered driver todrive the stopper and/or discharge the payload. The reservoir of theinjector may be oriented parallel to the skin of a subject and/orperpendicular to the skin and/or at an angle between parallel andperpendicular, for example between 60 to 90 degrees and/or between 30 to60 degrees and/or between 0 to 30 degrees. For the sake of thisapplication an internally powered injector driver may be defined as adrive mechanism powered by energy stored at least temporarily within theinjector. Power may be stored in a power supply, for instance aschemical potential (for example a chemical that produces an expandinggas and/or a battery) and/or mechanical potential (for example stored inan elastic member and/or a spring and/or a pressurized gas). For examplethe driver may be designed to discharge the payload over a time periodranging between 20 and 120 seconds and/or between 120 and 600 secondsand/or between 600 and 7200 seconds and/or longer. In some embodiments,discharge may be driven by a driver. An internally powered driver may bepowered by various mechanisms including for example a motor (includingfor example a DC motor, an actuator, a brushless motor) and/or atransmission including for example a telescoping assembly and/or athreaded element and/or a gear and/or a coupling and/or an elasticmechanism (for example a spring and/or a rubber band) and/or anexpanding gas and/or a hydraulic actuator).

A drug delivery device in accordance with some embodiments of thecurrent invention may include reservoir. For example a reservoir mayinclude a medicine container and/or a standard type syringe. Optionallya standard type syringe may be preloaded with medicine using standardequipment and/or in an aseptic room. A preloaded standard type syringemay optionally include a proximal opening. A stopper may optionally sealthe proximal opening and/or protect the sterility of the contents of thesyringe. A sterile needle (for example a hollow needle) may optionallybe connected to the syringe barrel. For example, the hollow of theneedle may be in fluid communication with the interior of the barrel.The needle may optionally be rigidly attached to the distal end of thebarrel. The sterility of all and/or part of the needle may for examplebe protected by a sterile cover. The sterile cover may remain on theneedle when the syringe is supplied and/or installed into an injector.For example, the medicine container may optionally include a cylindricalbarrel rigidly attached to a needle. Optionally, the long axes of theneedle and barrel of the syringe may be parallel and/or coaxial.Optionally, the needle may be mounted on the distal end of the barrel.Optionally the needle point may be pointing in the distal direction. Insome embodiments a stopper may slide axially along the inside of thebarrel to discharge a medicine payload. For example, the medicine may bedischarged through the hollow needle.

In some embodiments, a TSA may produce a force ranging for examplebetween 0.02 to 0.2 N and/or between 0.2 and 0.5 N and/or between 0.5 to5 N and/or between 5 to 60 N and/or between 60 to 90 N. For example theforce required to inject the drug may depend on the injection rateand/or the viscosity of the drug and/or the syringe geometry and/or theneedle dimensions.

In some embodiments, the stress to inject a medicine may include atorque. For example, injection of medicine may be driven by a stopper.The stopper may optionally be driven by a threaded assembly, for examplea threaded screw and/or teeth and/or a telescoping assembly. Optionallythe pitch of the teeth and/or an associated screw may range for examplebetween 0.5 and 2 mm. The diameter of the screw may range for examplebetween 3 and 15 mm. The torque to power injection may range for examplebetween 0.2 and 1.0 N*cm.

During injection, the linear movement of a stopper may range for examplebetween 5-40 mm and/or between 40-50 mm. The length of movement of thestopper may vary for example with the volume of medicine to be injectedthat may range for example between 0.5 to 3 ml and/or between 3 to 10ml.

It is expected that during the life of a patent maturing from thisapplication many relevant technologies will be developed and the scopeof the terms is intended to include all such new technologies a priori.

As used herein the term “about” refers to ±5%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

What is claimed is:
 1. A method of stabilizing a reservoir in a drugdelivery device comprising: inserting a reservoir in a housing of thedrug delivery device, the reservoir containing a drug and sealed with astopper; engaging a stopper adapter with the stopper of the reservoir;and anti-rotationally coupling an anti-rotational stabilizer to thehousing of the drug delivery device, wherein: anti-rotational guides anda telescoping assembly extend between the anti-rotational stabilizer andthe stopper adapter, the anti-rotational guides including telescopingposts anti-rotationally extending between the anti-rotational stabilizerand the stopper adapter, and the telescoping assembly telescopes byrelative rotation between at least a proximal shaft and a distal shaftoriented along an axis of the reservoir; the proximal shaft beinglinearly stabilized by a shoulder bearing of the anti-rotationalstabilizer, the shoulder bearing preventing movement of the proximalshaft in a proximal direction with respect to the anti-rotationalstabilizer while permitting rotation of the proximal shaft with respectto the anti-rotational stabilizer and the distal shaft being inengagement with the stopper adapter, whereby rotation of the proximalshaft with respect to the anti-rotational stabilizer is configured tomove the distal shaft and the stopper adapter along the axis, therebyslidably expanding the anti-rotational telescoping posts.
 2. The methodof claim 1, further including: rotating the proximal shaft with a motorof the drug delivery device.
 3. The method of claim 1, furthercomprising: engaging the reservoir, the stopper adapter, theanti-rotational stabilizer, the anti-rotational guides, and thetelescoping assembly to form a cartridge, and inserting the cartridge asa single unit into the drug delivery device.
 4. A method of supplying adrug to a delivery device comprising: providing an assembly for drivinga stopper in a drug reservoir of a drug delivery device, the assemblycomprising: an anti-rotational stabilizer anti-rotationally coupled to ahousing of the drug delivery device, a stopper adapter configured toengage the stopper of the drug reservoir, a telescoping assembly thattelescopes by relative rotation between at least a proximal shaft and adistal shaft oriented along an axis of the reservoir, the proximal shaftbeing linearly stabilized by a shoulder bearing of the anti-rotationalstabilizer, the shoulder bearing preventing movement of the proximalshaft in a proximal direction with respect to the anti-rotationalstabilizer while permitting rotation of the proximal shaft with respectto the anti-rotational stabilizer and the distal shaft being inengagement with the stopper adapter, and anti-rotational guidesincluding telescoping posts anti-rotationally extending between theanti-rotational stabilizer and the stopper adapter; and rotating theproximal shaft with respect to the anti-rotational stabilizer to movethe distal shaft and the stopper adapter along the axis thereby slidablyexpanding the anti-rotational telescoping posts.
 5. A method ofsupplying a drug to a delivery device comprising: providing an assemblyfor driving a stopper in a drug reservoir of a drug delivery device, theassembly comprising: a telescoping assembly that telescopes by relativerotation between at least a proximal shaft and a distal shaft orientedalong an axis of the reservoir; the distal shaft configured to engagethe stopper of the drug reservoir, an anti-rotational guide sized tomove along the axis of the reservoir; the anti-rotational guide slidablyand anti-rotationally coupled to a housing of the drug delivery device,a coupling slidably and anti-rotationally linking the anti-rotationalguide to the distal shaft; the sliding and anti-rotation with respect tothe axis of the reservoir such that rotating the proximal shaft withrespect to the anti-rotational guide moves the distal shaft along theaxis and moves the distal shaft with respect to the anti-rotationalguide, the anti-rotational guide also moving along the axis, and alinear stabilizer coupled to the proximal shaft, inhibiting axialmovement of the proximal shaft in a proximal direction with respect tothe linear stabilizer, the linear stabilizer coupled to the reservoirinhibiting axial movement of the linear stabilizer in a proximaldirection with respect to the reservoir, such that the rotation of theproximal shaft causes the distal shaft to advance distally inside of thedrug reservoir, wherein the linear stabilizer includes ananti-rotational connector fitting to the housing for preventing rotationof the linear stabilizer with respect to the housing; and slidablyengaging the anti-rotational guide to the housing by means of the linearstabilizer.